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Effectiveness of Surgery for Improving Survival in Oligometastatic Breast Cancer Patients (SASI-MBC)

17 maj 2026 uppdaterad av: Ghazia Qasmi, Sharif Medical Research Center

Effectiveness of Primary Tumour Surgery in Oligometastatic Breast Cancer for Improving Overall Survival: A Quasi-Experimental Study

Breast cancer is the most common malignancy in women, with stage IV disease at diagnosis in 5-10% of cases. Oligometastatic breast cancer (OMBC), defined as limited metastases (≤3-5 in ≤1-2 organs), may have better outcomes. Systemic therapy is the cornerstone of treatment, while the role of surgery or radiotherapy for the primary tumour remains controversial. Current European Society for Medical Oncology(ESMO )and National Comprehensive Cancer Network(NCCN) guidelines advise systemic therapy as standard, reserving surgery mainly for palliation of local disease. Few Retrospective studies offering primary tumour surgery to oligometastatic breast cancer responding to systemic therapy suggest survival benefit, but several randomised trials to date showed inconsistent results. In Pakistan, data regarding survival pattern after breast surgery in oligometastatic breast cancer are scanty and this study would bridge this knowledge gap.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Oligometastatic breast cancer (OMBC) is an entity is metastatic breast cancer with limited tumour burden. Usual nomenclature suggests total number of metastases to be less than 5 in up to 3 organs. It is considered an intermediate stage between localised and metastatic breast cancer. As compared to Multi metastatic stage 4 breast cancer oligometastatic breast cancer may have a favourable outcome (1,3) Currently the standard treatment for OMBC is systemic therapy (chemotherapy, hormone therapy or immunotherapy), with surgery or radiotherapy to primary tumour and metastatic sites as palliation only, as per ESMO and NCCN guidelines. (4,5) Retrospective observational studies suggested a possible survival benefit with primary tumour surgery (6,7). On the other hand, several Randomised controlled trials (Badwe et al., MF07-01, ECOG-ACRIN E2108, ABCSG-28) have shown inconsistent overall survival benefit with surgery in de novo metastatic breast cancer (8-10). The survival benefit has been observed where primary tumor surgery was performed in patients who respond well to systemic therapy in the form of complete or partial radiological response of metastasis, especially in patients with low metastatic burden, bone-only disease, or favorable biology may have differential outcomes after surgery (9,11).

Existing evidence is conflicting. So, case to case-based decision is being made for the oligometastatic breast cancer patients. There is a knowledge gap specific to oligometastatic disease among Pakistani patients as well. There are few Pakistani studies on this research question (12) The objective of this study is to determine whether surgical resection of the primary tumour in addition to standard systemic therapy improves overall survival compared with systemic therapy alone in patients with oligometastatic breast cancer.

Studietyp

Interventionell

Inskrivning (Beräknad)

110

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54910
        • Department of Surgery and Surgical Oncology

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Age ≥18 years
  • Histologically confirmed breast carcinoma
  • Oligometastatic disease (≤5 lesions, less than 3 organs)
  • ECOG performance status 0-2
  • Eligible for systemic therapy and surgery
  • Informed consent obtained

Exclusion Criteria:

  • Unfit for surgery
  • Prior locoregional surgery on primary tumor
  • Visceral crisis

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: breast surgery intervention group
breast cancer patients with metastasis who receive standard systemic therapy and have complete or partial radio logical response to metastatic deposits will be offered modified radical mastectomy or Breast conservation surgery in intervention group patients
Procedur: surgery in accordance with current clinical guidelines
MRM or BCS
Procedur: modified radical mastectomy or breast conservation surgery
patients who receive systemic therapy and respond to treatment will undergo modified radical mastectomy or breast conservation surgery
Inget ingripande: systemic therapy alone
breast cancer patients with oligometastasis receiving standard systemic chemo therapy ,hormone therapy or immunotherapy

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall survival
Tidsram: 3 years

Primary outcome measure of study will be overall survival in oligometastatic breast cancer patients after surgical intervention with chemotherapy versus chemotherapy alone. The time from intervention to the time of end point (death of patient) will be measured using this data through Kaplan Meier survival curve and using Cox regression model. We shall calculate:

  • Median survival
  • 3-year survival rate

  • Disease specific survival

    • Progression free Survival (PFS): Time from intervention to the progression will be measured using Kaplan-Meier survival method. End point of follow-up will be worsening of lesion, or appearance of new lesion, or death. We shall use RECIST criteria to record tumor change
    • Survival rate Total number of patients given intervention plus chemotherapy versus chemotherapy alone as denominator and total number of patients survived during follow-up time as numerator. Hazard Ratio will compare the risk of dying among intervention compared to control group.
3 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
1. Quality of life of breast cancer patients after intervention versus usual care(chemotherapy)
Tidsram: 3 years
QUALITY of life will be measured using EORTIC QUALITY OF LIFE QUESTIONNAIRE -BR 42 (QOL-42) Baseline quality of life of participants and the change in quality of life after intervention will be recorded. Patients will be interviewed after 3-months,6-months and then yearly. This tool assesses functional and symptom level domains on the scale of 0 to 100(better function=close to100; worse symptoms=close to100). Each item is scored from 1 to 4 (1 = not at all, 2= a little,3= quite a bit,4= very much).
3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sharif Medical Research Center

Samarbetspartners

Institute of Nuclear Medicine and Allied Sciences

Utredare

  • Huvudutredare: GHAZIA QASMI, FCPS SURGERY, SHARIF MEDICAL AND DENTAL COLLEGE, LAHORE.PAKISTAN
  • Studierektor: HAROON J. MAJID, FRCS SURGERY, SHARIF MEDICAL AND DENTAL COLLEGE LAHORE,PAKISTAN

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 juni 2028

Avslutad studie (Beräknad)

1 juni 2031

Studieregistreringsdatum

Först inskickad

23 april 2026

Först inskickad som uppfyllde QC-kriterierna

12 maj 2026

Första postat (Faktisk)

14 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SMDC/SMRC/409-26
  • SharifMRC (Annan identifierare: Sharif medical and dental college Lahore Pakistan)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

results of surgical intervention as overall and progression free survival.quality of life proforma results,patients demographics, treatment given

Tidsram för IPD-delning

from march 2031 onwards

Kriterier för IPD Sharing Access

researchers through published paper

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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